Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Recall
- Recall Number
- Z-0009-2024
- Event Number
- 92785
- Firm
- Boston Scientific Corporation
- FEI Number
- 3002095335
- Product Code
- DQY
- Status
- Open, Classified
- Root Cause
- Employee error
- Initiated
- July 27, 2023
- Posted
- October 3, 2023
- Address
- 1 Scimed Pl, Maple Grove, MN, 55311-1565
Description
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Stryker issued an URGENT: MEDICAL DEVICE VOLUNTARY Recall notice to it consignees on 07/31/2023. The notice explained the issue, potential risk, and required the following actions be taken: 1. Immediately check your internal inventory for affected devices. 2. Segregate the affected units in a secure location for return to Stryker. 3. Circulate this Recall-Removal notice internally to all interested/affected parties. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Inform Stryker if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that Stryker can inform the recipients appropriately.
US Nationwide distribution in the state of Indiana.
4990 units